Device, System And Method For Operating A Digital Radiograph

ABSTRACT

A handheld radiographic device is provided, the device may include an X-ray detector adapted to provide a digital radiographic frame of a dynamic image of an object under investigation, a position determination subsystem adapted to provide position data associated with a digital radiographic frame and an image processing controller adapted to combine multiple radiographic frames using the position data associated with each of the radiographic frames and thus to produce a static image. Moreover, a method is provided for producing a static image from multiple radiographic frames using a handheld radiographic device.

BACKGROUND

The number of radiological examinations emanating from interactions atmedical “points of care” is staggering. Patients involved in accidentsor suffering other forms of trauma are often in need of timelyradiological examinations at the initial point of medical contact (forexample, accident site, trauma centers, health clinic and physician'soffice).

The lack of on-site examinations results in a reduced quality oftreatment and higher costs of health care. Furthermore, the need to sendpatients to radiological centers or hospitals for evaluations reduces aphysician's revenue stream.

Fluoroscopy is a dynamic radiographic technology. Presently, there existdevices that employ X-rays or other types of radiation to producefluoroscopic or transitory images and radiographic images for diagnosticpurposes. These devices are bulky and heavy and are fixed in location.Most of such units, by their nature, produce large dosage of X-rays andconsume large amounts of power necessitating specialized electricalpower sources and, for “mobile” units, heavy and bulky arrays ofbatteries. Even so called “portable” or “mini” units typically weighover 100 kg and are portable only by the virtue of special carts thatfacilitate limited movement.

Furthermore, many X-ray systems currently in use for both fluoroscopyand radiography employ high intensity x-radiation, which high intensityis dictated, in large part, by the relatively low gain or limited degreeof light amplification provided by conventional image intensificationtechniques. The high radiation intensities employed in these systemsalso require the use of X-ray tubes employing large area focal spotssince otherwise the high beam currents would generate too much heat andlead to rapid deterioration of the tube anode (unless cooled by a bulkycooling mechanism). X-ray tubes employing large area focal spotsnecessitate operation at long source to image distances in order tomaintain satisfactory image resolution or definition. As such, thesesystems must be operated by specialized personnel working inLead-shielded environments, in order to protect the patient, theoperator, and other people located in the surrounding environment.

Also, it is not practical to “scale down” existing solutions, in orderto fulfill the needs for “on site” radiological examinations. This isbecause a scaled down unit would produce a field of view that is toosmall to be practical for most applications. Such a device alreadyappears in the prior art, but it does not fulfill the requirements ofpoint of care applications.

Typically, X-ray C-arm devices which are named C-arms because of therepresentative shape of the assembly (which resembles the letter “C”)may be mounted on a stationary assembly that facilitates manipulation inorder to view a wide range of body parts. These assemblies are by naturestationary and are typically housed in a specially-designed radiologycenter. “Portable” or “mini” C-arms that exist in the market (GE Lunar,OEC, Xitec, Toshiba and others) are devices that are mounted on movablecarts. They typically weigh hundreds of pounds and require a truck tomove them from place to place. Other manufactured portable C-arms(manufactured by Lixi Corp., for example) are powered byradiologically-active isotopes. These devices are unwieldy and areimpractical for use in the field.

There is thus a need to develop improved portable X-ray radiographs foruse at the initial point of medical intervention.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, not limiting in scope. Invarious embodiments, one or more of the above-described problems havebeen reduced or eliminated, while other embodiments are directed toother advantages or improvements.

In one embodiment of the present disclosure, a handheld radiographicdevice is provided, the device may include an X-ray detector adapted toprovide a digital radiographic frame of a dynamic image of an objectunder investigation, a position determination subsystem adapted toprovide position data associated with a digital radiographic frame andan image processing controller adapted to combine multiple radiographicframes using the position data associated with each of the radiographicframes and to produce a static image. In another embodiment, thecontroller may further be adapted to produce a dynamic imagesuperimposed over a static image.

In another embodiment of the present disclosure, a system is provided,the system may include a handheld radiographic device, the device mayinclude an X-ray detector adapted to provide a digital radiographicframe of a dynamic image of an object under investigation, a positiondetermination subsystem adapted to provide position data associated witha digital radiographic frame and an image processing controller adaptedto combine multiple radiographic frames using the position dataassociated with each of the radiographic frames and to produce a staticimage. In another embodiment, the controller may further be adapted toproduce a dynamic image superimposed over a static image.

In another embodiment of the present disclosure, a method is providedfor producing a static image from multiple radiographic frames using ahandheld radiographic device, the method may include producing a digitalradiographic frame of a dynamic image of an object under investigation,providing position data associated with the digital radiographic frameand combining multiple radiographic frames using the position dataassociated with each of the radiographic frames to produce a staticimage. In another embodiment, the method may further include producing adynamic image superimposed over a static image.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a handheld radiographic device,according to some embodiments of the present disclosure;

FIG. 2 (A-B) are schematic block diagrams of the system, according tosome embodiments of the present disclosure;

FIG. 3 (A-C) are schematic diagrams of the system, according to someembodiments of the present disclosure;

FIG. 4 (A-B) are schematic diagrams of the system, according to someembodiments of the present disclosure;

FIG. 5 is a schematic diagram of the system (A) and a possibleradiographic frame (B) obtained by the system, according to someembodiments of the present disclosure;

FIG. 6 is a schematic diagram of the system (A) and a possible staticimage (B) obtained by the system, according to some embodiments of thepresent disclosure;

FIG. 7 is a schematic diagram of the system (A) and a possible dynamicimage superimposed on a static image (B) obtained by the system,according to some embodiments of the present disclosure;

FIG. 8 illustrates a flow chart of a method, according to someembodiments of the present disclosure; and

FIG. 9 is a schematic diagram of the robotic arm, according to someembodiments of the present disclosure.

It will be appreciated that for simplicity and clarity of illustration,elements shown in the figures have not necessarily been drawn to scale.For example, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity. Further, where consideredappropriate, reference numerals may be repeated within the figures toindicate like elements.

DETAILED DESCRIPTION

The following description is presented to enable one of ordinary skillin the art to make and use the disclosure as provided in the context ofa particular application and its requirements. Various modifications tothe described embodiments will be apparent to those with skill in theart, and the general principles defined herein may be applied to otherembodiments. Therefore, the present disclosure is not intended to belimited to the particular embodiments shown and described, but is to beaccorded the widest scope consistent with the principles and novelfeatures herein disclosed. In other instances, well-known methods,procedures, and components have not been described in detail so as notto obscure the present disclosure.

Unless specifically stated otherwise, as apparent from the followingdiscussions, it is appreciated that throughout the specificationdiscussions utilizing terms such as “processing”, “computing”,“calculating”, “determining” and the like, refer to the action and/orprocesses of a computer or computing system, or similar electroniccomputing device, that manipulates and/or transforms data represented asphysical, such as electronic, quantities within the computing system'sregisters and/or memories into other data similarly represented asphysical quantities within the computing system's memories, registers orother such information storage, transmission or display devices.

In one embodiment of the present disclosure, a handheld radiographicdevice is provided, the device may include an X-ray detector adapted toprovide a digital radiographic frame of a dynamic image of an objectunder investigation, a position determination subsystem adapted toprovide position data associated with a digital radiographic frame andan image processing controller adapted to combine multiple radiographicframes using the position data associated with each of the radiographicframes and to produce a static image.

In another embodiment of the present disclosure, a system is provided,the system may include a handheld radiographic device, the device mayinclude an X-ray detector adapted to provide a digital radiographicframe of a dynamic image of an object under investigation, a positiondetermination subsystem adapted to provide position data associated witha digital radiographic frame and an image processing controller adaptedto combine multiple radiographic frames using the position dataassociated with each of the radiographic frames and to produce a staticimage. In another embodiment, the controller may further be adapted toproduce a dynamic image superimposed over a static image. In anotherembodiment, the controller may further be adapted to produce a dynamicimage superimposed over a static image, wherein the dynamic image issuperimposed on the correct place on the static image. In anotherembodiment, the correct place may refer to the place of a certainpartial image in a larger image.

According to some embodiments, the device may include a C-arm shapedelement. According to some embodiments, the device may be structured asa C-arm (or a micro C-arm) which may incorporate any one of thefollowing design characteristics:

The device may be small enough to be portable. According to otherembodiments, the device may be self-contained. In some embodiments, theterms “portable device” or “handheld device” may refer to a deviceadapted to being carried, deployed, and operated by non-specializedradiation personnel. In other embodiments, self-contained may refer to asystem which is operational without the need for additional externalelements (other than those provided in this document).

The device may provide the energy levels and resolution necessarygenerate images static and dynamic fluoroscopic images that are usefulfor the application.

The device may be safe for use by non-specialized personnel innon-shielded environments, for a number of examinations that areroutinely performed by such personnel.

According to some embodiments, the terms “radiography”, “radiograph” or“radiographic” may refer to the creation of images by exposing an imagereceptor to X-ray. According to some embodiments, the terms“fluoroscopy”, “fluoroscope” or “fluoroscopic” may refer to an imagingtechnique for obtaining real-time images of the internal structures ofan object by irradiating the object with X-ray irradiation.

Reference is now made to FIG. 1, which is a schematic illustration of anexemplary handheld radiographic device, structured as a micro C-armportable fluoroscopic X-ray device (100), according to some embodimentsof the present disclosure. The device includes a grip handle (102) witha radiation cover shield (103) connected on one side to an X-ray source(104) and on the other side to an X-ray detector (106). The upper partof the C-arm includes an onboard viewing monitor (107) and a controlpanel (108) or the data may be transmitted to a remote monitor orstorage medium (110). The lower part of the C-arm includes a powersupply element (112). The system's power supply may or may not beincorporated into the C-arm itself.

Reference is now made to FIG. 2A, which is a schematic block diagram(200) of the system, according to some embodiments of the presentdisclosure. The system may include, according to some exemplaryembodiments, a main controller (202) connected to a control panel (204),a power supply digital interface (206), a receiver (208), an imageintensifier (210), a memory (212), an LCD controller (214), a tiltsensor (215) and a transmitter (218) which may transmit a signal to aremote receiving device, for example, a PC (220). The control panel(204) is connected to the digital interface (206). The power supplydigital interface (206) combines between main controller (202) and theX-ray power supply (222) which is connected to an X-ray tube (224). Theimage intensifier (210) is also connected to the memory (212). The LCDcontroller (214) also connects to an LCD (226).

In operation, according to some embodiments, the main controller (202),which is adapted to manage the entire system and regulate the flow ofinformation from the system memory to the output device, after receivinga signal from the control panel (204), signals the digital interface(206) to activate the X-ray power supply (222) which results in emissionof X-ray radiation by the an X-ray tube (224). The X-ray radiation maypenetrate an object under inspection and impinge upon the imageintensifier (detector) (210), which includes a surface sensitive toX-ray radiation and is capable of converting X-ray energy intoelectrical signals, whereby the electrical signals are used to buildmultiple radiographic frames of the object under observation. Eachdigital radiographic frame obtained may be transferred to the memory(212). In addition, each digital radiographic frame is associated withdata relating to its relative position within the whole image of theobject under observation, which data is obtained by the receiver (208)which receive signals from three transmitters (227, 228, 229) located inthree different positions. The tilt angle may be obtained using the tiltsensor (215). The main controller (202) may be adapted to operate as animage processing controller and may be adapted to combine multiple theradiographic frames using the position data associated with each of theradiographic frames, to produce a static image and to produce a dynamicimage superimposed over a static image. The signals representing theimages may be transmitted to a remote receiving device, for example, aPC computer (220). The signals representing the images may also betransmitted to an LCD controller (214) and presented on an LCD (226).The LCD may also show the system's menus related to ongoing systemoperation and displays the object under observation when the system isactive.

Reference is now made to FIG. 2B, which is a schematic block diagram(200) of the system, according to some embodiments of the presentdisclosure. The system may include, according to some exemplaryembodiments, a main controller (202) connected to a control panel (204),a power supply digital interface (206), a track ball (207), an imageintensifier (210), a memory (212), an LCD controller (214), a tiltsensor (215) and a transmitter (218) which may transmit a signal to aremote receiving device, for example, a PC (220). The control panel(204) is connected to the power supply digital interface (206). Thedigital interface (206) combines between main controller (202) and theX-ray power supply (222) which is connected to an X-ray tube (224). Theimage intensifier (210) is also connected to the memory (212). The LCDcontroller (214) also connects to an LCD (226).

In operation, according to some embodiments, the main controller (202),which is adapted to manage the entire system and regulate the flow ofinformation from the system memory to the output device, after receivinga signal from the control panel (204), signals the digital interface(206) to activate the X-ray power supply (222) which results in emissionof X-ray radiation by the an X-ray tube (224). The X-ray radiation maypenetrate an object under inspection and impinge upon the imageintensifier (detector) (210), which includes a surface sensitive toX-ray radiation and is capable of converting X-ray energy intoelectrical signals, whereby the electrical signals are used to buildmultiple radiographic frames of the object under observation. Eachdigital radiographic frame obtained may be transferred to the memory(212). In addition, each digital radiographic frame is associated withdata relating to its relative position within the whole image of theobject under observation, which data is obtained by the track ball(207). The tilt angle may be obtained using the tilt sensor (215). Themain controller (202) may be adapted to operate as an image processingcontroller and may be adapted to combine multiple the radiographicframes using the position data associated with each of the radiographicframes, to produce a static image and to produce a dynamic imagesuperimposed over a static image. The signals representing the imagesmay be transmitted to a remote receiving device, for example, a PCcomputer (220). The signals representing the images may also betransmitted to an LCD controller (214) and presented on an LCD (226).The LCD may also show the system's menus related to ongoing systemoperation and displays the object under observation when the system isactive.

In accordance with embodiments the device may incorporate a navigation(position determination) system (or subsystem) to “know where it is” atall times so that when the device is in operation, the picture frames itgenerates are stored and then used to build composite views. In thisway, a small image intensifier/detector can produce an effective picturemuch larger than the field of view provided by the detector itself. Inaddition, according to other embodiments, the system may thus preventsthe exposure of already exposed parts.

According to some embodiments, the navigation (position determination)system (or subsystem) may include one or more of the following systems:

According to some embodiments, the position determination subsystem mayinclude an inertial navigation (positioning) system.

Every object that is free to move in space has six “degrees offreedom”—or ways it can move. There are three linear degrees of freedom(x,y,z) that specify the position of the object and three rotationaldegrees of freedom (theta (pitch), psi (yaw), and phi (roll)) thatspecify the attitude of the object. If these six variables are known, itis possible to know where the object is and which way it is pointed. Aninertial navigation system provides the position, velocities andattitude of an object by measuring the accelerations and rotationsapplied to the system's inertial frame. It refers to no real-world itembeyond itself.

The Inertial navigation system may include, according to someembodiments, a passive system mounted on the device (for example theC-arm) and may be used to detect motion whenever the device is moved. Inthis way, the system may store relative spatial coordinates for eachframe exposure of the device as it is moved. As the device moves,according to some embodiments, the system may build a composite X-rayimage of the individual frames, superimposing each frame exactly whereit should be in relation to the object under investigation.

In another embodiment, the position determination subsystem may includea system that transmits positioning information to a sensor mounted onthe device (for example the C-arm). Such a system may include multipletransmitters (RF, ultrasound or others) that are mounted either on thesubject under investigation, on a stand, or otherwise located within thereceiving range of the device's detector. By triangulating the signalsfrom the multiple transmitters, the system may record relative spatialcoordinates for each frame exposure of the device as the device ismoved. As the device moves, the system may build a composite X-ray imageof the individual frames, superimposing each frame exactly where itshould be in relation to the object under investigation. According tosome embodiments, the device can be used in a moving frame of reference(for example, a moving car or ambulance), since it is not dependent on a“fixed frame of reference” for positioning information.

According to some embodiments, the position determination subsystem mayinclude a receiver adapted to receive a signal from asignal-transmitting element. According to other embodiments, the signalmay include a radio frequency (RF), infra-red (IR), ultrasonic signal orany combination thereof.

Reference is now made to FIGS. 3 (A-C), which are schematic diagrams ofthe system from different view points, according to some exemplaryembodiments. The system (300) may include a (C-arm shaped) handhelddevice (302) having a receiver/controller (304) adapted to receiveposition related signals from a number of transmitters. The system'snavigation capabilities are provided by a navigation subsystem thatconsists of three registration points (306), (308) and (310) each ofwhich contains a transmitter and the receiver/controller (304) that islocated on the C-arm. In accordance with some embodiments, thenavigation system may be responsible for maintaining the correct spatiallocation data of at least the following: each static image slice that isgenerated by the C-arm and up to date (and ongoing) location data of theC-arm, in relation to the object under observation.

According to some embodiments, the position determination subsystem mayinclude a cursor located on the lower or upper part of the device,wherein the cursor is adapted to output a signal proportional to therelative distance done by the cursor. According to other embodiments,the signal may include an electrical signal. According to otherembodiments, the relative distance may be measured by mechanical (forexample but not limited to, a track ball), optical means (for examplebut not limited to, IR) or a combination thereof. According to otherembodiments, the cursor may be adapted to move on a planar surface.According to other embodiments, the planar surface may further include astabilizing element adapted to stabilize the object under examination.

Reference is now made to FIG. 4 (A-B), which are schematic diagrams ofthe system from two view points, according to some exemplaryembodiments. The system (400) may include an X-ray radiographic device(402) as described herein, which includes a cursor (404) and a slidingelement (406) adapted to move on a planar surface (408). The planarsurface may further include a stabilizing element (410) adapted tostabilize the object under examination.

According to some embodiments, the device may further include a tiltsensor adapted to provide the spatial angle of the device (for examplethe upper part of the C-arm or the X-ray source) in relation to acertain reference surface or in relation to the object underinvestigation (for example a hand or leg).

According to some embodiments, the detector (also referred to herein asan image interface) may include an X-ray target, wherein the X-raytarget may include an X-ray sensitive element adapted to provide thedynamic image. According to other embodiments, the X-ray sensitiveelement may include a scintillation screen.

The X-ray sensitive element is capable of converting X-ray energy intoelectrical signals, whereby the electrical signals are used to build animage of the object under observation (a “meaningful” or as referred toherein, a dynamic image). The interface may be digital, analog orcombination thereof and may use either direct or indirect methods forgenerating an image of the object under observation.

The image interface may be located at one end of the C-arm, in thetraditional fashion of conventional C-arms. According to someembodiments, the device may enable the incorporation of a meaningfulsize of an effective field of view (for example, about 6″) while keepingthe device weight low. These set of components used in the detector,according to some embodiments, allows the use of the X-ray data to showa continuous picture.

In one embodiment the term “field of view” may refer to the size of anactual radiographic frame obtained by an intensifier/detector. The fieldof view, according to some embodiments, may be about 2″. The field ofview, according to some embodiments, may be between 1-4″. The field ofview, according to some embodiments, may be between 2-4″.

In another embodiment the term “effective field of view” may refer to animage obtained by an intensifier/detector by combining a multiplicity ofradiographic frames. The device may thus produce an effective picture(based on an effective field of view) larger than the field of viewprovided by the detector itself. The device may produce an effectivepicture (based on an effective field of view), which is theoretically,unlimited in size. The device, according to some embodiments, mayproduce an effective field of view larger than 5″. The device, accordingto other embodiments, may produce an effective field of view larger than6″. The device, according to other embodiments, may produce an effectivefield of view larger than 10″. The device, according to otherembodiments, may produce an effective field of view larger than 12″. Thedevice, according to other embodiments, may produce an effective fieldof view larger than 15″. The device, according to other embodiments, mayproduce an effective field of view larger than 20″. The device,according to other embodiments, may produce an effective field of viewcomparable to those produced by static X-ray cameras which utilizesplates, for example 11″×17″. The device, according to other embodiments,may produce an effective field of view limited only by the memory of thesystem and by the resolution of the picture.

According to some embodiments, the detector may include ahigh-resolution semiconductor chip, a flat panel, an image intensifieror any combination thereof. According to other embodiments, the detectormay include a selenium-based element. According to other embodiments,the high-resolution semiconductor chip may include a Charged CoupledDevice (CCD), CMOS or a combination thereof. According to otherembodiments, the flat panel may include an amorphous silicon-based photosensor. According to some embodiments, the detector may include anydirect or indirect. Direct-conversion detectors have an X-rayphotoconductor, such as but not limited to, amorphous selenium thatdirectly converts X-ray photons into an electric charge.Indirect-conversion detectors, have a scintillator that first convertsX-rays into visible light. That light is then converted into an electriccharge by means of photo detectors such as amorphous silicon photodiodearrays or CCDs. Thin-film transistor (TFT) arrays may be used in bothdirect and indirect conversion detectors. In both direct and indirectconversion detectors, the electric charge pattern that remains after theX-ray exposure is sensed by an electronic readout mechanism, andanalog-to-digital conversion is performed to produce the digital image.Any other appropriate X-ray detector may be used, for example detectorsdisclosed in(http://www.agfa.com/en/he/knowledge_training/technology/direct_indirect_conversion/index.isp)which is herein incorporated by reference.

According to some embodiments, the output of the device may be one ormore of the following:

a dynamic image (also referred to herein as a real time image) forexample, a fluoroscopic image;

a static image of object under investigation; and

a dynamic image superimposed over a static image of the object underobservation.

Reference is now made to FIG. 5, which is a schematic diagram of thesystem (B) and a possible radiographic frame of a dynamic image (A)obtained by the system, according to some embodiments of the presentdisclosure. The device (502) may scan the object under inspection, forexample an arm (504) and provide a radiographic frame of a dynamic image(506).

Reference is now made to FIG. 6, which is a schematic diagram of thesystem (B) and a possible static image (A) obtained by the system,according to some embodiments of the present disclosure. The device(602) may scan the object under inspection, for example an arm (604) andprovide a static image (606). The static image (608) may be produced bycombining multiple radiographic frames using position data associatedwith each of the radiographic frames.

Reference is now made to FIG. 7, which is a schematic diagram of thesystem (B) and a possible dynamic image superimposed on a static image(A) obtained by the system, according to some embodiments of the presentdisclosure. The device (702) may scan the object under inspection, forexample an arm (704) and provide a dynamic image (706) superimposed on astatic image (708).

According to some embodiments, the device may further include a viewingmonitor. According to other embodiments, the viewing monitor may be anon-board monitor or a remote monitor.

According to some embodiments, the device may include a liquid crystaldisplay (LCD). According to other embodiments, the LCD may include anoperation panel. In another embodiment, the device may include anexternal output to video monitor. In another embodiment, the device mayinclude an external output to video recorder. In another embodiment, thedevice may include an external output to computer for furtherprocessing.

According to some embodiments, the external image presentation/analysisapparatus may be connected to the device either using standard cables(for example, coax) or may be transmitted via wireless connection, usingan appropriate standard (for example, Bluetooth, Wi-Fi, and other meansof wireless connection).

According to some embodiments, by passing the information to an externalcomputer, the exemplary following applications (and any other possibleapplication) may be facilitated: bone densiometric measurements of asubject, three-dimensional analysis of X-ray images, image enhancementsof X-ray movie, photo montage, other processing of X-ray images andimage compression for sending to a remote operator/analyst for furtheranalysis. In one embodiment, the device may include a touch screen LCDmonitor on board (on the C-arm, for example) with the device's commandsshown directly on the monitor.

In one embodiment, the device provides the ability to offer a predefinedset of procedures, so that the operator does not have to manually X-rayand then perform the specific analysis. Rather, the operator may choosea menu item that may configure the C-arm, may take the X-ray, and maypost-process the image to provide the necessary output. An example ofthis would be the device's ability to automatically perform densiometricanalyses, without having to do it in several manual steps.

According to some embodiments, the device may further include an X-raysource. According to other embodiments, the X-ray source component maygenerate the radiation needed to create a fluoroscopic image. Inaccordance with some embodiments, the X-ray may be a commerciallyavailable X-ray tube that may generate the X-ray beam needed toilluminate the object under observation. According to some embodiments,the X-ray tube assembly may be smaller/lighter than X-ray tubes used,for example, in health care centers and therefore, may be more portable.

According to some embodiments, the device may include a power supplyelement adapted to supply voltage to the X-ray source and to switch thevoltage on and off to prevent the X-ray source and the X-ray tube fromoverheating. According to other embodiments, the X-ray tube may notrequire cooling. According to other embodiments, the X-ray tube mayinclude an air-cooling mechanism. According to other embodiments, thepower supply may be able to provide higher power while being much moreelectrically efficient than X-ray devices used, for example, in healthcare centers and therefore, may be more portable.

According to some embodiments, the use of the circuitry described hereinmay limit the scattered radiation and therefore may reduce the amount ofradiation to which the subject and operator are exposed. The device maythus require no lead aprons for the intended applications.

According to other embodiments, the power supply element may providebetween 1-70 kVP. According to other embodiments, the power supplyelement may provide between 10-60 kVP. According to other embodiments,the power supply element may provide between 20-70 kVP. According toother embodiments, the power supply element may provide between 40-70kVP. According to other embodiments, the power supply element mayprovide between 10-40 kVP. According to other embodiments, the powersupply element may be lower than 30 kVP.

As non-limiting examples, according to some embodiments, the currentapplied to the X-ray source may be between 0.05-0.5 mA. According toother embodiments, the current applied to the X-ray source may bebetween 0.05-0.25 mA. According to other embodiments, the currentapplied to the X-ray source may be between 0.1-0.25 mA. According toother embodiments, the current applied to the X-ray source may bebetween 0.1-0.2 mA. According to other embodiments, the current appliedto the X-ray source may be lower than 0.2 mA.

The control system, according to some embodiments, which may also bereferred to herein as a “controller” or “main controller”, may consist,of a user interface panel and the associated control mechanism needed tooperate the device, as well as required safety features mandated by law.

The control panel of the device may include one or more of thefollowing, or any combination thereof: switches embedded within thedevice assembly, a control panel connected to the device via a cableassembly, a control panel connected to the device via a wirelessconnection (for example, a wireless remote control), a foot switch forturning the device on or off, a foot-operated controller (for example, amouse or a joystick) for positioning and controlling the device. Theoperator may also be able to select from system menus using thefoot-operated controller. According to some embodiments, the controlpanel may incorporate any one or combination of the followingfunctionality, or any other appropriate feature: a system power on/offswitch, a fluoroscope on/off switch (and/or foot switch, and/or timerthat shuts the system off automatically), a voltage selector, a currentselector, a voltage and current selector may be combined into one“exposure setting”. In another embodiment, the controller may alsocontain necessary safety features dictated for devices that generateX-rays. Some functions supported by the control system may include, butnot limited to, the following: an automatic shutoff switch that may turnthe system off in case the tube or circuitry overheats, a fuse assembly,a voltage limiter, a current limiter or any combination thereof.

According to some embodiments, the device may be adapted to remotecontrol operation. The device (for example, the C-arm) may becontrollable by a remote controller (for example, a joystick or mouse).Using the controller (which may be mounted directly on the arm, may beremote controlled, or may be operated by foot), the operator canposition the imaging device.

According to some embodiments, the device may include a foot pedaladapted to operate the device at least partially. In one embodiment, theability to control the device using a foot may be useful in that anoperator, for example a surgeon, may be able to use both handssimultaneously and operate the imaging device with their foot. This isespecially important to surgeons using the device to assist them duringsurgery (for example, minimally invasive surgery).

According to some embodiments, the device may be adapted to operate in anon-shielded environment. According to other embodiments, the device maybe operated by non-specialized personnel (for example, a person nottrained to operate X-ray devices, such as a medic or a paramedic in anaccident site).

As part of the present disclosure a method is provided for producing astatic image from multiple radiographic frames using a handheldradiographic device, the method may include producing a digitalradiographic frame of a dynamic image of an object under investigation,providing position data associated with the digital radiographic frameand combining multiple radiographic frames using the position dataassociated with each of the radiographic frames to produce a staticimage.

Reference is now made to FIG. 8, which illustrates a flow chart (800) ofa method for producing a static image from multiple radiographic framesusing a handheld radiographic device, according to some embodiments ofthe present disclosure. The method may include producing a digitalradiographic frame of a dynamic (real time) image of an object underinvestigation (802), providing position data associated with the digitalradiographic frame (804), combining multiple radiographic frames usingthe position data associated with each of the radiographic frames (806),producing a static image (808) and optionally producing a dynamic imagesuperimposed over a static image (810).

According to some embodiments, the method may further include producinga dynamic image superimposed over a static image. According to otherembodiments, the method may include providing position data associatedwith the digital radiographic frame comprises using an inertialnavigation system. According to other embodiments, the method mayinclude providing position data associated with the digital radiographicframe comprises using a receiver adapted to receive a signal from asignal-transmitting element. According to other embodiments, the methodmay include providing position data associated with the digitalradiographic frame comprises using a cursor located on the lower part ofthe device, wherein the cursor is adapted to output a signalproportional to the relative distance done by the cursor. According toother embodiments, the method may include remotely operating the device.According to other embodiments, the method may include operating thedevice using a robotic arm.

According to embodiments of the invention, the device may supportseveral modes of operation:

In one embodiment the device may support a dynamic mode of operation. Inthis mode, the system provides dynamic (for example, fluoroscopic)images in real-time on the on-board monitor or on a remote monitor orstorage device. The system may be activated either by a hand or footswitch.

According to an embodiment of the invention, the device may operate likea conventional device in a dynamic mode of operation.

In another embodiment the device may support a “Stills” mode ofoperation (for producing a still image). In this mode, the operatorscans the device across the object of interest. As the device moves (orthe object moves in relation to a stationary device), the system recordsa set of “snapshot” images; each image is a picture of the areacurrently illuminated by the X-ray beam. At the end of this “scanning”motion, a composite image is built that represents the entire scannedobject as one image. The system corrects for non-uniform motion of theoperator, as well as inadvertent motion of the patient. There is no needto remain absolutely still during the examination. In this way, thesystem is able to produce a much larger image of an object than would beprovided by conventional device (i.e. a “snapshot” photo using thedevice is much larger than the size of the detector).

According to an embodiment of the invention, the system may build acomposite still image from a set of image “slices.” The system mayoperate this mode using some registration points (for example three orfour) that are located either on the object under observation or on asurface to which the object under observation is affixed (and stationaryin respect to this surface). Examples of such a surface may include asplint or support. At each registration point a transmitter is locatedthat generates a signal (either ultrasonic, electronic or optic) that isreceived by a receiver (and controller) mounted on the device. Thereceiver and controller calculate the location of the device for everyimage slice that is generated by the device. For each image captured,the system assigns the spatial coordinates of the image slice. During orfollowing the scan, the system uses the spatial location data togenerate a composite image by correctly “pasting” the individual imageslices together.

In another embodiment the device may support a “mixed” mode ofoperation. In this mode the operator is able to view a dynamic (forexample, fluoroscopic) image superimposed on top of the still image thatwas generated by the system (using the “Stills” mode). The system isable to correctly position the dynamic image in the correct place sothat the operator is able to see a real-time dynamic image in theappropriate location of the object of interest. In this way, theoperator is able to examine a specific point of interest using adynamic, fluoroscopic image, while maintaining the macroscopicperspective of where the point is located on the scanned object.

According to an embodiment of the invention, the system generates acomposite image as described above (“stills mode”). After the image isgenerated, the operator can use the device to view the object underobservation, as described above (“dynamic mode”). In this case, however,the dynamic image appears “superimposed” on the still image generatedvia the scan. As the operator moves the device, the dynamic image mayalways be shown correctly superimposed on the object of interest. Inthis way, the operator can focus on a specific part of the object underobservation, while maintaining the macroscopic perspective of where thissection appears on the overall object. The system may use the device'snavigation capabilities (the position of the C-arm in relation to theobject) to correctly position the real-time, dynamic image on top of thepreviously generated “stills” image.

In one embodiment, the invention provides the ability to offer apredefined set of procedures, so that the operator does not have tomanually X-ray and then perform the specific analysis. Rather, theoperator may choose a menu item that may configure the C-arm, may takethe X-ray, and may post-process the image to provide the necessaryoutput. An example of this would be the device's ability toautomatically perform densiometric analyses, without having to do it inseveral manual steps.

The device, according to some embodiments, may produce an effectivefield of view that is larger than provided by the source/detectorcomponents.

According to other embodiments, the device may produces a real-time,dynamic, fluoroscopic image correctly superimposed on a static image ofthe object under investigation, so that an operator (such as aphysician, an X-ray technician, emergency medical personnel and others)can “drill down” to investigate a specific area on the object, whileretaining the macroscopic perspective of the area's location in relationto the object at large. The portable fluoroscope may be practical forpoint of care and emergency applications.

According to other embodiments, the device may provide the ability todisplay both a visible photograph superimposed over the X-ray view ofthe subject. In this way, the viewer can see where on the subject thearea of interest is located. For example, if an operator is looking fora broken bone, they can see a photo of the arm superimposed over theX-ray, so they can see where on the body the break has occurred.

According to some embodiments, the device may incorporate the followingexemplary characteristics. In one embodiment, the device may be smallenough to be portable and self-contained. In another embodiment,portable may mean able to be carried, deployed, and operated bynon-specialized radiation personnel. In one embodiment, self-containedmay mean that the system is operational without the need for additionalexternal elements (other than those provided in this document). Inanother embodiment, the device may provide the energy levels andresolution necessary generate images static and dynamic fluoroscopicimages that are useful for diagnostic applications. In anotherembodiment, the device may be safe for use by non-specialized personnelin non-shielded environments, for a number of examinations that areroutinely performed by such personnel.

The device may, according to some embodiments, incorporate adjustablearms that may allow the X-raying of items of varying depth. This featuremay facilitate the X-raying of different size objects (for example, bodyparts). In one embodiment, the portable device may enable the adjustmentof the “throat depth” (which may be defined, in accordance with someembodiments, as the distance between the X-ray source and the target) inorder to conform to the requirements of a specific object underinspection. In one embodiment, the portable device may enable a motionthat increases/decreases the distance between the X-ray tube and thetarget (detector), as well as changes the “throat depth” of the device(for example, a C-arm) to get around large object. In accordance withsome exemplary embodiments, the throat depth may be between 5-20″. Inaccordance with other exemplary embodiments, the throat depth may bebetween 10-19″. In accordance with other exemplary embodiments, thethroat depth may be between 12-17″. In accordance with other exemplaryembodiments, the throat depth may be about 15″.

The device may open and close like a clam around an object thatrepresents an obstacle to X-raying the subject. According to someembodiments, the controller may be adapted to turn off the power supplyto the X-ray source if the distance between the X-ray source and theobject under inspection decreases below a predetermined value.

According to some embodiments, the device may further include a tiltsensor adapted to provide the spatial tilt angle. The tilt angle may be,according to some embodiments, the angle between the device (for examplethe upper part of the C-arm or the X-ray source) and a certain referencesurface such as of the object under investigation (for example a hand orleg). According to some embodiments, the controller may be adapted toturn off the power supply to the X-ray source if the tilt angle ishigher than a predetermined value. In one embodiment, the predeterminedvalue may be 92°. In another embodiment, the predetermined value may be95°. In another embodiment, the predetermined value may be 100°.According to some embodiments, the controller may be adapted to turn offthe power supply to the X-ray source if the tilt angle is lower than apredetermined value. In one embodiment, the predetermined value may be87°. In another embodiment, the predetermined value may be 85°. Inanother embodiment, the predetermined value may be 80°.

In accordance with some exemplary embodiments the weight of the devicemay be between 5-15 lbs. In accordance with other exemplary embodimentsthe weight of the device may be between 7-10 lbs. In accordance withother exemplary embodiments the weight of the device may be lower than10 lbs. In accordance with other exemplary embodiments the weight of thedevice may be lower than 7 lbs. In accordance with other exemplaryembodiments the weight of the device may be lower than 5 lbs.

According to some embodiments, the portable device may provide imageanalysis as part of the system output. Examples of image analysisinclude, but are not limited to, bone densiometry, image enhancement,compression for transmitting the images wirelessly to a remote terminal.

According to other embodiments, scales (linear, angular or both) can beviewed on the device's display. Thus, the display may allow the operatormeasure distances or angles between multiple points of interest on thesubject, directly on the screen. The scales may also be saved with thephoto so that it can be printed out or used for later analysis.

According to other embodiments, the system may include a “back off”function that may allow an operator X-ray a subject and then move thedevice out of the way. A subsequent command may return the device toprecisely the position and orientation that existed prior to the “backoff” command. This feature may be useful for surgeons, performingoperations, for example, where they want to be able to remove the devicemomentarily (for example, so that they can position themselves betterwith respect to the patient). Once they want to view the subject again,the device may be returned to its original position without having to doany manual manipulation. This feature may be controlled by the footcontroller so that the surgeon can keep both hands available for theoperation.

In one embodiment, the device may be structured as a C-arm which isnamed a C-arm because of the representative shape of the assembly (whichresembles the letter “C”). Typically, X-ray C-arm devices which arenamed C-arms because of the representative shape of the assembly (whichresembles the letter “C”) may be mounted on a stationary assembly thatfacilitates manipulation in order to view a wide range of body parts. Ingeneral, according to some embodiments, the C-arm mechanical assemblymay serve any one the following purposes or any combination thereof. TheC-arm mechanical assembly may house the X-ray source assembly, properlyposition the source and target assemblies, house the monitoring anddiagnostic components (for example, CCD camera, LCD viewing monitor,output ports for external monitoring and diagnostic equipment, and otherelements), provide for the positioning and manipulation of the X-raydevice (which may include at least one of hand grips for holding andmanually positioning the device and mounting bracket for connecting theC-arm to a stationary platform or mobile apparatus that manipulates andmaintains the position of the C-arm during operation, provide thecontrols for the X-ray device (the control may optional be operationalvia remote control, depending on the application) and provides a safeenvironment for radiological examination (for the subject and for theoperator). The basic C-arm assembly may a mechanical assembly that mayfacilitate the functionality described herein.

In accordance with some embodiments, there may be several other featuresbuilt into the C-arm mechanical assembly for example, onboard videomonitor (via LCD screen for example) built onto the C-arm itself. Inaccordance with other embodiments, the device may include certainmaterials (such as but not limited to, titanium) to achieve extremelylightweight assembly, so that device is usable by non-specializedpersonnel.

According to some embodiments, the device, which may be shaped as aC-arm may incorporate a unique support stand that may allow the operatorto use the radiograph without having to hold it in place. The device maybe operated using one hand or alternatively using no hands (operatingthe device using the foot controller, or possibly a head up display), sothat the operator can view the subject in three-dimensions while thehands free for other tasks. According to some embodiments, the supportstand may support a linear motion and a rotational motion. According tosome embodiments, the support stand may include a docking station.

A linear motion, according to some embodiments, may allow an operator totraverse or scan an object. For example, a physician can take acontinuous X-ray of a patient's forearm. Furthermore, the system mayautomatically build a composite photo from different frames of thefluoroscopic movie made while the device scans the object.

Rotational motion, according to other embodiments, may permit a complete360° rotation along two axes (simultaneously). This allows the operatorto develop a three-dimensional view of the subject at hand. Imagingsoftware supplied with the device may present a three-dimensional viewof the object under observation for detailed analysis. The C-arm may ofcourse, disengage from the C-arm stand so that it can be used in afree-standing position by the operator.

According to some embodiments, the device may include a robotic arm.According to some embodiments, the device, which may be shaped as aC-arm may include a robotic arm that may be able to accurately positionthe device, for example, in minimally invasive procedures. According tosome embodiments, the following functionalities of the device's roboticarm may be achieved. The device may be moved in and out of position witha “memory” command that remembers where the device was located before itwas removed. The device may be controlled via a foot “mouse” that maymove the device according to the operator's foot motion. The device maybe controlled by following the motion of tools that are held by theoperator. Therefore, as the operator moves a tool (for instance ascalpel, a needle or any other tool used during a medical procedure)relative to the subject under investigation, the device may move inorder to illuminate that specific place in space. A schematic diagram ofa system, which may be operated using a robotic arm, is shown in FIG. 9,according to some embodiments. The system (900) includes a robotic arm(902) connected to an X-ray radiographic device as described herein, forexample a C-arm (904). The robotic arm (902) is connected to the C-armusing a gripper (906). The system may be operated by the controlsubsystem (908) which may include a monitor, for example, a two screenmonitor (910) and a control panel (912) which may include a key pad anda track ball.

According to additional embodiments, some add-ons to the device mayinclude a suitcase that incorporates a viewing screen for true mobility.The device can be kept in a hardened case and taken to the field. Oncethere, the operator can view a large picture by flipping up the top ofthe case and viewing the picture on the screen. Connections to thismonitor can be done using wires or via a wireless technology.

According to additional embodiments, add-ons to the device may include aplastic covers surgery. In another embodiment, add-ons to the device mayinclude a foot pedal or trigger pull. In another embodiment, add-ons tothe device may include dual screen operators. In another embodiment,add-ons to the device may include a stand. In another embodiment,add-ons to the device may include a robotic arm that may change thegeometry of the C-arm to view objects of different dimensions (e.g.thicker or wider). In another embodiment, add-ons to the device mayinclude markers that may be placed on the object under observation, sothat the unit can synchronize the position of the object with thereal-time fluoroscopic view.

Non-limiting examples of applications for the device include but notlimited to medicine, orthopedic applications (extremities), veterinarymedicine (including equine), sports medicine, military medicine,emergency medicine, geriatric medicine, security (including on-sitepackage inspection and screening), industry (including inspection ofwelds and the structural integrity of objects including for example,aviation components, marine vessels, supports, large immobile structuressuch as buildings, pipes, electronic components and assemblies) and anyother relevant application.

1. A handheld radiographic device comprising: an X-ray detector adaptedto provide a digital radiographic frame of a dynamic image of an objectunder investigation; a position determination subsystem adapted toprovide position data associated with a digital radiographic frame; andan image processing controller adapted to combine multiple radiographicframes using the position data associated with each of the radiographicframes and to produce a static image.
 2. The device of claim 1, whereinsaid controller is further adapted to produce a dynamic imagesuperimposed over a static image.
 3. The device of claim 1, wherein saidposition determination subsystem comprises an inertial navigationsystem.
 4. The device of claim 1, wherein said position determinationsubsystem comprises a receiver adapted to receive a signal from asignal-transmitting element.
 5. The device of claim 4, wherein saidsignal comprises a radio frequency (RF), infra-red (IR), ultrasonicsignal or any combination thereof.
 6. The device of claim 1, whereinsaid position determination subsystem comprises a cursor located on thelower part of said device, wherein said cursor is adapted to output asignal proportional to the relative distance done by said cursor.
 7. Thedevice of claim 6, wherein the relative distance is measured bymechanical, optical means or a combination thereof.
 8. The device ofclaim 6, wherein said cursor is adapted to move on a planar surface. 9.The device of claim 6, wherein said planar surface further comprises astabilizing element adapted to stabilize the object under examination.10. The device of claim 1, wherein said detector comprises an X-raytarget, wherein said X-ray target comprises an X-ray sensitive elementadapted to provide the dynamic image.
 11. The device of claim 10,wherein said X-ray sensitive element comprises a scintillation screen.12. The device of claim 1, wherein said detector comprises ahigh-resolution semiconductor chip, a flat panel, an image intensifieror any combination thereof.
 13. The device of claim 1, wherein saiddetector comprises a selenium-based element.
 14. The device of claim 12,wherein said high-resolution semiconductor chip comprises a CCD, CMOS ora combination thereof.
 15. The device of claim 12, wherein said flatpanel comprises an amorphous silicon-based photo sensor.
 16. The deviceof claim 1, further comprising an X-ray source.
 17. The device of claim1, adapted to remote control operation.
 18. The device of claim 1,further comprising a viewing monitor.
 19. The device of claim 1, whereinsaid viewing monitor is an on-board monitor or a remote monitor.
 20. Thedevice of claim 1, adapted to operate in a non-shielded environment. 21.The device of claim 1, further comprising a foot pedal adapted tooperate said device at least partially.
 22. The device of claim 1,further comprising a liquid crystal display (LCD).
 23. The device ofclaim 22, wherein said LCD comprises an operation panel.
 24. The deviceof claim 1, wherein said device comprises a C-arm shaped element. 25.The device of claim 1, further comprising a robotic arm.
 26. A methodfor producing a static image from multiple radiographic frames using ahandheld radiographic device, the method comprising: producing a digitalradiographic frame of a dynamic image of an object under investigation;providing position data associated with the digital radiographic frame;and combining multiple radiographic frames using the position dataassociated with each of the radiographic frames to produce a staticimage.
 27. The method of claim 26, further comprising producing adynamic image superimposed over a static image.
 28. The method of claim26, wherein providing position data associated with the digitalradiographic frame comprises using an inertial navigation system. 29.The method of claim 26, wherein providing position data associated withthe digital radiographic frame comprises using a receiver adapted toreceive a signal from a signal-transmitting element.
 30. The method ofclaim 29, wherein said signal comprises a radio frequency (RF),infra-red (IR), ultrasonic signal or any combination thereof.
 31. Themethod of claim 26, wherein providing position data associated with thedigital radiographic frame comprises using a cursor located on the lowerpart of said device, wherein said cursor is adapted to output a signalproportional to the relative distance done by said cursor.
 32. Themethod of claim 31, wherein the relative distance is measured bymechanical, optical means or a combination thereof.
 33. The method ofclaim 31, wherein said cursor is adapted to move on a planar surface.34. The method of claim 31, wherein said planar surface furthercomprises a stabilizing element adapted to stabilize the object underexamination.
 35. The method of claim 26, further comprising remotelyoperating the device.
 36. The method of claim 26, further comprisingoperating the device using a robotic arm.